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Clinical Trials in China / NCT07123545
Recruiting Phase 1/2

Autologous Neoantigen-Specific T-Cell Therapy for Advanced Hepatocellular Carcinoma

NCT07123545 · tracked via the Priya Life Science China tracker
Sponsor
Zhejiang University
Phase
Phase 1/2
Started
2025-08-01
Last updated
2025-08-14

Condition(s) studied

Advanced Hepatocellular Carcinoma (HCC)

Investigational drug(s) / intervention(s)

iNeo-Vac-P01 Personalized Neoantigen Peptide VaccineiNeo-Vac-T01 Personalized T Cell Injection

iNeo-Vac-P01 Personalized Neoantigen Peptide Vaccine: Administered subcutaneously at 0.3 mg/peptide on Days 1, 4, 8, 15, 22, 52, and 82, followed by booster immunizations every 2-3 months.

iNeo-Vac-T01 Personalized T Cell Injection: Administered via intravenous infusion: Dose Level 1: 5×10⁹ to 10×10⁹ cells; Dose Level 2: 1×10¹⁰ to 5×10¹⁰ cells.

Study summary

The goal of this open-label, single-arm phase I/II clinical trial is to evaluate the feasibility, safety, and anti-tumor efficacy of the autologous neoantigen-specific T-cell therapy (iNeo-Vac-T01) in patients with advanced hepatocellular carcinoma who have failed second-line or later systemic therapies.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Aged 18 to 75 years (inclusive) 2. Histologically confirmed advanced hepatocellular carcinoma (HCC) with: <!-- --> 1. Radiologically measurable disease per RECIST v1.1 2. Documented progression on ≥2 prior lines of systemic therapy 3.Life expectancy ≥6 months 4.ECOG performance status 0 or 1 5.Available archival or fresh tumor tissue sufficient for comprehensive genomic profiling OR existing whole-genome sequencing (WGS), whole-exome sequencing (WES), or RNA-sequencing data meeting prespecified quality thresholds 6.Adequate organ and marrow function: (1)Hematologic: 1. White blood cell count (WBC) ≥3.0 × 10⁹/L 2. Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L 3. Hemoglobin ≥9.0 g/dL (≥5.6 mmol/L) 4. Platelet count ≥100 × 10⁹/L (2)Hepatic: a.Total bilirubin ≤1.5 × upper limit of normal (ULN) (≤3 × ULN if liver metastases present) b.Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × ULN (≤5 × ULN if liver metastases present) (3)Renal: 1. Serum creatinine ≤1.5 × ULN OR 2. Calculated creatinine clearance (CrCl) ≥50 mL/min (Cockcroft-Gault formula) (4)Coagulation: <!-- --> 1. International normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN AND activated partial thromboplastin time (aPTT) ≤1.5 × ULN (unless receiving therapeutic anticoagulation with stable INR/PT/aPTT within target range) 7.Reproductive Status: 1. Women of childbearing potential (WOCBP): Negative serum pregnancy test within 7 days prior to treatment initiation AND agreement to use highly effective contraception during study participation and for ≥120 days after last study intervention 2. Men: Agreement to use barrier contraception during study participation and for ≥120 days after last study intervention 8.Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures Exclusion Criteria: 1.History of other active malignancies within the past 5 years, except: 1. Adequately treated basal cell or squamous cell skin cancer 2. Carcinoma in situ of the cervix 3. Other malignancies considered cured with minimal risk of recurrence (e.g., localized thyroid cancer) 2.Failure to identify therapeutically targetable neoantigens via genomic analysis 3.Prior allogeneic bone marrow, solid organ, or hematopoietic stem cell transplantation 4.Active or symptomatic central nervous system (CNS) metastases except: (1)Previously treated CNS metastases that are radiologically stable (no evidence of progression) for ≥4 weeks and (2)Asymptomatic and off corticosteroid/anticonvulsant therapy for ≥4 weeks prior to enrollment (3)Note: Leptomeningeal disease is excluded regardless of stability or treatment status. 5.Active bacterial, fungal, or mycobacterial infection requiring systemic therapy (including untreated latent tuberculosis) 6.Active viral infections meeting any of the following: 1. Detectable HBV DNA (if HBsAg positive or HBcAb positive) 2. Detectable HCV RNA 3. HIV infection (serologically confirmed) 4. Active syphilis infection (serologically confirmed) 7.Active autoimmune disease requiring systemic immunosuppressive therapy (\>10 mg prednisone equivalent daily) within the past 2 years, except: <!-- --> 1. Vitiligo 2. Type 1 diabetes mellitus 3. Hypothyroidism stable on hormone replacement 4. Psoriasis not requiring systemic therapy 8.Systemic immunosuppressive therapy (\>10 mg prednisone equivalent per day) within 14 days prior to planned cell infusion (topical, inhaled, or ophthalmic corticosteroids are permitted) 9.Uncontrolled intercurrent illness including, but not limited to: (1)New York Heart Association (NYHA) Class III or IV congestive heart failure (2)Unstable angina pectoris (3)Uncontrolled cardiac arrhythmia (4)Uncontrolled hypertension (≥160/100 mmHg despite medication) (5)Clinically significant pulmonary disease 10.History of substance abuse or psychiatric/social condition that would impair ability to provide informed consent or comply with study requirements 11.History of severe (Grade ≥3) hypersensitivity reactions to vaccine components or investigational products, or any condition deemed by the investigator to pose an unacceptable risk for immunotherapy 12.Any condition that, in the opinion of the Investigator, would compromise patient safety or interfere with study participation or interpretation of results

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting

More Zhejiang University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07123545 on ClinicalTrials.gov ↗ ← All trials in China